MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	ETBF2813C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	02/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an unknown size abdominal aortic aneurysm.It was reported that when the patient returned for a follow ct where the physician observed a type ia endoleak.The physician attributed the cause of the endoleak to disease progression due to anatomy.No additional clinical sequelae were reported and the patient is being monitored.
Additional Manufacturer Narrative
Additional information received reported that intervention was performed approximately 1 month post follow up ct.No further information is available.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7406134
• Report Number: 2953200-2018-00522
• Device Sequence Number: 19119328
• Product Code: MIH
• UDI-Device Identifier: 00613994991294
• UDI-Public: 00613994991294
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2016
• Device Model Number: ETBF2813C145E
• Device Catalogue Number: ETBF2813C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR